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冠心病和/或瓣膜病合并心房颤动患者行心脏手术伴左房手术消融与不伴心房消融的比较:PRAGUE-12 随机多中心研究的最终结果。

Comparison of cardiac surgery with left atrial surgical ablation vs. cardiac surgery without atrial ablation in patients with coronary and/or valvular heart disease plus atrial fibrillation: final results of the PRAGUE-12 randomized multicentre study.

机构信息

Cardiocenter, Third Faculty of Medicine, Charles University Prague, Czech Republic.

出版信息

Eur Heart J. 2012 Nov;33(21):2644-52. doi: 10.1093/eurheartj/ehs290. Epub 2012 Aug 28.

DOI:10.1093/eurheartj/ehs290
PMID:22930458
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3485575/
Abstract

AIMS

Surgical ablation procedure can restore sinus rhythm (SR) in patients with atrial fibrillation (AF) undergoing cardiac surgery. However, it is not known whether it has any impact on long-term clinical outcomes.

METHODS AND RESULTS

This multicentre study randomized 224 patients with AF scheduled for valve and/or coronary surgery: group A (left atrial surgical ablation, n = 117) vs. group B (no ablation, n = 107). The primary efficacy outcome was the SR presence (without any AF episode) during a 24 h electrocardiogram (ECG) after 1 year. The primary safety outcome was the combined endpoint of death/myocardial infarction/stroke/renal failure at 30 days. A Holter-ECG after 1 year revealed SR in 60.2% of group A patients vs. 35.5% in group B (P = 0.002). The combined safety endpoint at 30 days occurred in 10.3% (group A) vs. 14.7% (group B, P = 0.411). All-cause 1-year mortality was 16.2% (A) vs. 17.4% (B, P = 0.800). Stroke occurred in 2.7% (A) vs. 4.3% (B) patients (P = 0.319). No difference (A vs. B) in SR was found among patients with paroxysmal (61.9 vs. 58.3%) or persistent (72 vs. 50%) AF, but ablation significantly increased SR prevalence in patients with longstanding persistent AF (53.2 vs. 13.9%, P < 0.001).

CONCLUSION

Surgical ablation improves the likelihood of SR presence post-operatively without increasing peri-operative complications. However, the higher prevalence of SR did not translate to improved clinical outcomes at 1 year. Further follow-ups (e.g. 5-year) are warranted to show any potential clinical benefit which might occur later.

摘要

目的

心脏手术中,外科消融术可恢复心房颤动(AF)患者的窦律(SR)。但目前尚不清楚它对长期临床结局是否有影响。

方法和结果

这项多中心研究将 224 名拟行瓣膜和/或冠状动脉手术的 AF 患者随机分组:A 组(左房外科消融术,n = 117)与 B 组(无消融术,n = 107)。主要疗效终点为术后 1 年 24 小时心电图(ECG)时 SR 存在(无任何 AF 发作)。主要安全性终点为 30 天时死亡/心肌梗死/卒中和肾功能衰竭的复合终点。术后 1 年 Holter-ECG 显示 A 组 60.2%的患者出现 SR,B 组为 35.5%(P = 0.002)。30 天的复合安全性终点在 A 组为 10.3%,B 组为 14.7%(P = 0.411)。全因 1 年死亡率为 A 组 16.2%,B 组 17.4%(P = 0.800)。卒中有 2.7%(A)和 4.3%(B)患者发生(P = 0.319)。在阵发性(61.9% vs. 58.3%)或持续性(72% vs. 50%)AF 患者中,A 组与 B 组之间的 SR 无差异,但在持续性永久性 AF 患者中消融显著增加了 SR 的发生率(53.2% vs. 13.9%,P < 0.001)。

结论

外科消融术可提高术后 SR 存在的可能性,而不增加围手术期并发症。然而,SR 发生率的增加并未在 1 年内转化为改善的临床结局。需要进一步随访(例如 5 年),以显示可能发生的后期潜在临床获益。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/47e7/3485575/e7849432f76f/ehs29002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/47e7/3485575/d90d18061838/ehs29001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/47e7/3485575/e7849432f76f/ehs29002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/47e7/3485575/d90d18061838/ehs29001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/47e7/3485575/e7849432f76f/ehs29002.jpg

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